Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
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Articles and Reports
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Medical Necessity Requirement Bites Anatomic Pathologists
By Robert Mazer bio
The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains…
FDA Sends 14 Warning Letters Regarding Cancer Products
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to…
Theranos Settles with CMS and Arizona Attorney General
From - National Intelligence Report
After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to…
CMS, OIG Reps Address PAMA, Fraud Enforcement at ACLA Annual Meeting
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OIG and DOJ Provide Tips for Determining Effectiveness of Compliance Programs
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Health Care Fraud and Abuse Program Faces Declining ROI
From - National Intelligence Report
The federal government's return on investment (ROI) in the fight against health care fraud continues a steady decline according to the latest numbers reported for the Health Care Fraud and…
Breach Notification Violation Ends in $475,000 Settlement
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